Manager, Quality Assurance

NWRPros; Vancouver; Hybrid; CAD 135,000 - 185,000; Full time

Job summary

NWRPros is recruiting a Manager, Quality Assurance to ensure cGMP compliance for investigational medicinal products. This role partners with clinical, regulatory, and manufacturing teams to review batch records, investigations, and change controls.

You will oversee eQMS content, training programs, supplier QA, and inspections readiness, driving continuous improvement and adherence to ICH GXP and GMP standards.

Qualifications

• B.S. in a science-related discipline (preferably chemistry/biochemistry/chemical engineering).
• 8+ years in biotech or pharma with GMP operations, process development/tech transfer/manufacturing/testing/CMC.
• Knowledge of GCP; clinical operations experience is a plus.
• Experience with eQMS tools, project planning tools, and Excel.

Responsibilities

• Ensure compliance with ICH GXP guidelines and applicable regulations.
• Spearhead continuous quality improvement activities.
• Oversee eQMS content, coordination, and execution.
• Define and manage employee training programs via the eQMS.
• Coordinate external and internal audits and gap analyses.
• QA oversight of contract manufacturers and labs.

Skills

Quality mindset

Cross-functional collaboration

Auditing

Documentation

Regulatory knowledge

Education

B.S. in science (chemistry/biochemistry/chemical engineering)

Tools

eQMS Tools

Smartsheet

Excel

Job description

Manager, Quality Assurance
Location: West Coast US+Canada (Hyrbid)
The Manager, Quality Assurance, is responsible for ensuring investigational medicinal products (IMPs) meet current Good Manufacturing Practices (cGMP). This role serves as a quality partner to internal teams, executing hands-on batch reviews, investigations, vendor management and compliance oversight while seamlessly bridging the gap between technical, clinical, and regulatory operations.

Key responsibilities and duties:

• Ensure procedures and systems are established and maintained to ensure the Company’s compliance with ICH GXP guidelines; current national and international legislation; and relevant regulations, standards and guidelines
• Spearhead continuous quality improvement activities
• Oversee the implementation, manage the content, coordination, and execution of our client’s electronic Quality Management System (eQMS).
• Define and manage the delivery of training programs for employees via the eQMS
• Coordinate external audits, internal audits and gap analyses
• Manage the QA oversight of contract manufacturers and testing labs (internal/external) to ensure products/deliverables meet all required quality standards and specifications.
• Perform rapid and agile record review and disposition activities for clinical trial material including manufacturing, testing and labelling/packaging batch records
• Lead extensive investigations with vendors and interdepartmental teams to determine product quality impact and resolve potential product quality issues.
• Act as the single point of QA contact with vendors, contract facilities and joint development collaborators for contracts, validation activities, change management and other QA issues
• Drive the implementation of other quality systems, including departmental and corporate procedures, to ensure compliance with GXPs.
• Review CMC documents submitted to regulatory agencies.
• Develop work instructions and/or standard operating procedures
• Lead inspection readiness preparation and training
• Review and approve new procedures, specifications, analytical methods and other quality documentation as required
• Collaborate cross-functionally to ensure the implementation of required procedures, best practices and adherence to regulatory requirements and GCP guidelines
• Negotiate and maintain Quality Agreements with GXP service providers
• Build and maintain strong working relationships with members of the CMC, Regulatory Clinical Operations and Supply Chain teams

Education, qualifications and work experience:

• B.S. in a science related discipline (preferably in chemistry, biochemistry, or chemical engineering)
• 8+ years related experience in the biotechnology or pharma industry with a sound knowledge and focus on GMP operations, process development/technology transfer validation/ manufacturing/testing/ CMC or equivalent combination of education and experience
• Knowledge of GCP and experience with clinical operations would be an asset
• Demonstrated experience with eQMS Tools, Gantt Charts, Excel Spreadsheets and Project Planning tools, Smartsheet
• Experience in planning, organizing and conducting audits.
• Experience in preparing for inspections ideal
• Able to work collaboratively in a matrix structure while ensuring that timelines and deliverables are met.
• Critical thinker, outgoing and enthusiastic and well-organized.
• Excellent written, spoken, listening and presentation skills and a demonstrated ability to influence within the wider project team at the level of functional leadership.
• Self-motivated; able to work independently and within a team
• Excellent time management and multi-tasking skills
• Maintains a composed, collaborative and independent manner when dealing with issues, challenges, conflicts and opportunities.

Salary Range:

• $95,000 to $130,000, depending on education and relevant experience

While only short-listed candidates will be notified, we thank each applicant for their submission